The SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant, and 2) to characterize sensing and conversion of induced VF up to 90 days post-implant.
The primary safety objective of the study is to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant. The primary performance objective is to characterize sensing and conversion of induced VF up to 90 days post-implant. Up to 3 Investigational Sites Worldwide will participate with up to 20 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires sub-chronic evaluation of the lead up to 90 days. Subjects will receive a concomitant EV-ICD System, comprising the investigational EV-ICD Lead connected to a commercially available ICD. Prior to discharge, the EV-ICD will be programmed to monitor only to detect and store ventricular arrhythmias over the 90-day follow-up period. After the EV-ICD System is removed (up to 90 days post-implant), the Subject will be followed for an additional 30 days then exit the study. The duration of study participation for an individual Subject is 120 ± 7 days. The study is expected to complete within 6 months of the first enrollment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
18
Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.
Sanatorio Italiano
Asunción, Paraguay
Incidence of ADEs
Incidence of Adverse Device Effects (ADEs)
Time frame: Up to 120 days post-implant
Induced VF Conversion Success
Induced VF conversion success with ≥10 J safety margin 60-90 days post-implant
Time frame: Up to 90 days post-implant
Lowest Defibrillation Conversion Energy
Lowest Defibrillation Conversion Energy (J) at implant with left mid-axillary PG location
Time frame: Procedure
Induced VF Conversion Success - Implant
Induced VF conversion success rate at implant with left pectoral PG location
Time frame: Procedure
Induced VF Conversion Success - 30 Days
Induced VF conversion success with ≥10 J safety margin at 30 days
Time frame: Up to 30 days post-implant
Sensing and Detection of Ventricular Arrhythmias
Ability to automatically sense and detect induced and spontaneous ventricular arrhythmias
Time frame: Up to 90 days post-implant
Detection Time for VT/VF
Detection time for spontaneous VT/VF episodes recorded during follow-up by the permanent TV-ICD System and concomitantly implanted investigational EV-ICD System
Time frame: Up to 90 days post-implant
Detection Time and Time-to-Therapy
EV-ICD VF detection time and time-to-therapy
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Time frame: Up to 90 days post-implant
Brady Pacing Electrical Performance: Pacing Capture Threshold
Pacing Capture Threshold (V)
Time frame: Up to 90 days post-implant
Brady Pacing Electrical Performance: Pacing Impedance
Pacing Impedance (ohms)
Time frame: Up to 90 days post-implant
Brady Pacing Electrical Performance: R-wave Amplitude
R-wave Amplitude (mV)
Time frame: Up to 90 days post-implant